Evaluating clinical efficacy of ayurvedic inhalation therapy(aerosol) and rasayan therapy in the management of COPD-a randomised cohort control clinical study

All India Institute of Ayurveda0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•a.Age- 18-60 years.
•b.Both male and female
•c.Smokers and ex-smoker with smoking history>=10 pack-years
•d.Newly diagnosed COPD (GOLD stage I & II): post-bronchodilator FEV1/FVC ratio <0.7); FEV1 >=50 and <80% of predicted normal; MRC dyspnoea score >=2.
•e.Ability to demonstrate compliance with handy-inhaler, a salbutamol Meter Dose Inhaler, and the activity monitor; perform acceptable Pulmonary FunctionTests; an exercise stress test and can follow study procedures.
•f. No acute exacerbation of COPD.
•g. Clinically being stable for one month and longer.
•h.Not undergoing exercise training program or any other lung rehabilitation therapy.

•a.COPD of GOLD stage III & IV with FEV1 <50%.
•b.COPD with life threatening complications like cor-pulmonale, respiratory failure, pneumothorax and polycythemia.
•c.Any history of previous chronic infectious respiratory disease like tuberculosis, URTI, acute bronchitis, pneumonia.
•d.Patient taking steroid therapy from long duration (systemic or inhaled corticosteroid)
•e.Diagnosis of asthma.
•f.History of cystic fibrosis.
•g.Past or current malignancy within 5years.
•h.Pregnant ladies and lactating mothers.
•i.History of any adverse drug reactions.
•j.Patients having positive HIV1 and 2 or positive Hepatitis B.
•k.Patients having end stage hepatic dysfunction (defined asaspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 4 times of the upper normal limit) or severe renal dysfunction (defined as S. creatinine > 1.2 mg/dl),severely compromised cardiac function (EF < 30% ).
•l.Patient with poorly controlled Hypertension ( > 160 / 100 mm Hg).

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